The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children

NCT00580151 | Terminated Results

• 2 other identifiers: 04-101IFFA
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Some of the children who suffer acute burn injury do not have adequate pain and anxiety management with the current regimen of scheduled opiates (morphine) and benzodiazepines (lorazepam). Other children have significant side effects or contraindications, such as constipation or over sedation, when taking these medications. Clonidine is known to reduce the need for morphine in the management of postoperative pain. The addition of clonidine to the pharmacological treatment of burn wound pain offers a possible adjunct to the standard opiate and benzodiazepines regimen. Clonidine has been used in children in both on a short-term basis (such as postoperative pain management) and on a long-term basis (such as the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to the management of pain and anxiety in the acutely burned child. All children will be treated by protocol with morphine (0.03mg/kilo) q4hr prn pain and lorazepam (0.03 mg/kilo) q 4 hours prn anxiety. In addition, after informed consent is obtained the children will be randomized to the addition clonidine or placebo. Pain and anxiety will be assessed using standard instruments blind to the medication being used on a daily basis Also the total dose of morphine and lorazepam during the 10 days of added clonidine or placebo will be recorded.. The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose will be compared between the placebo and clonidine groups with a Student's t test. Once the blind is broken the child will be allowed to remain on the clonidine if it is beneficial. The second year of the grant will expand the age groups down to younger children and also begin to gain information about the effect of clonidine on the hypermetabolic state secondary to burn injury.

Conditions

Pain; Anxiety

Keywords

Pain not controled by morphine; Anxiety not controled by lorazepam

Outcome Measures

Primary Outcomes (1)

• Pain Reduction

  The scale name is "FACES" (Faces Pain Rating Scale). Subjects were asked "rate your WORST PAIN today" (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged.

  Average of the 10 days

Secondary Outcomes (1)

• Anxiety Reduction

  Average of the 10 days

Study Arms (2)

1

EXPERIMENTAL

Drug: clonidine

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

clonidine DRUG

3-5 microgram per kilogram every 6 hours for 10 days

1

placebo DRUG

1 dose every 6 hours

2

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pain not controled by morphine
• Anxiety not controled by lorazepam
• Burn injuries of 20% or greater
• Burn type: scald or flame

You may not qualify if:

• Small burn injury
• Electrical burns

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Shriners Hospital for Children; Shriners Burns Hospital

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

No Adverse Events Recorded.

Results Point of Contact

• Title: Walter Meyer, M.D.
• Organization: University of Texas-Galveston

wmeyer@utmb.edu

409-770-6718

Study Officials

• Walter J. Meyer III, MD

  The University of Texas Medical Branch at Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 24, 2007
• Study Start: June 1, 2004
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Locations

US (1)